Health Condition 1: C50- Malignant neoplasm of breast
Conditions
Interventions
Intervention1: CDK 4/6 Inhibitors with or without Hormonal therapy: Patients who fit in inclusion criteria will receive one of the CDK 4/6 Inhibitors- Palbociclib, Ribociclib or Abemaciclib with or wi
Sponsors
Department of Medical Oncology, Goa Medical College, Bambolim, Goa
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged =18 years with metastatic breast cancer confirmed by imaging (CT/MRI/PET-CT/USG) with ER+/HER2- status confirmed by immunohistochemistry or fluorescent in situ hybridization
Exclusion criteria
Exclusion criteria: 1) Prior treatment with any of the CDK4/6 inhibitors. 2) Pregnant or breastfeeding women. 3) Known hypersensitivity to any of the CDK4/6 inhibitors or components of the therapy. 4) Any other concurrent malignancies within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. 5) Eastern Cooperative Oncology Group (ECOG) performance status 4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the impact of CDK 4/6 inhibitors in combination with hormonal therapy on quality of lifeTimepoint: 0 months and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor adverse effects associated with the combination therapy.Timepoint: every month for 3 months and as and when new side effects develop | — |
Countries
India
Contacts
Public ContactDr Darshan Kanani
Goa Medical College and Hospital, Goa
Outcome results
None listed